NEWS: Specificity in Fluid

Color-coordinated syringes and pouches help users adhere to a topical remedy program.

To create dispensing accuracy for clinical trials, one company devoted to women’s health seeks to meet its needs through packaging.

The Wiley Protocol, a biomimetic, rhythmic hormone restoration therapy plan, utilizes syringes to dispense precise dosages of topical supplements for men and women with lowered hormones owing to aging and underactive glands. The topical creams, formulated to mimic hormones, are absorbed through the skin.

The company relies on syringes from Comar (Buena, NJ), caps from Qosina (Edgewood, NY), and printed, color-coordinated bags from Impak/Sorbent Systems (Los Angeles) to create accurate, targeted treatment plans. Clinical trials soon will be under way, and patients’ full compliance to the system is critical to gaining FDA approval.

“Right now, the state of BHRT [bio-identical hormone replacement therapy] is creams or preparations that mimic the template of the standard of care in their dosing schedules,” says creator T.S. Wiley. She distances herself from BHRT, believing that negative patient reactions could stem from nonstandardized, nonbiomimetic rhythm dosing.

The National Institutes of Health through the Women’s Heath Initiative published a series of articles in April 2008 discussing increased incidents of stroke in women who take synthetic hormones. Natural remedies such as BHRT have no FDA approval and are not under its scrutiny. Although this means she could avoid FDA’s watch, Wiley instead chooses to obtain its approval by conducting clinical trials.

Success lies in packaging, which can aid accurate dispensing for specific dosing necessary during the trials. Comar syringes allow for specific dosing with delineated marks along the syringe. Qosina stoppers in place of rubber gaskets prevent material from leaching and contaminating the pharmaceutical-grade creams.

“And they’re pretty,” Wiley says. “Women appreciate that.” Wiley Systems, which packages the protocol, sells up to a half-million syringes a year, and Wiley estimates that by the end of the year it will rise to 1 million.

A typical package given to users includes product and instructions in a laminate pouch, color-coordinated to match the syringes. The estradiol pack, for example, features nine 3-ml syringes with green plungers and green Qosina caps in a green package with a dosing schedule on the back. Wiley says users dispense a prescribed amount of lines of product on their arms, day and night, one arm for each hormone. Dosage varies through the month.

“Comar, Sorbent, and Qosina have massively improved compliance and stability of the hormone,” she says. Other compliance materials include patient directional inserts and a calendar with symptom observation codes for individual response reporting. The calendar helps users adhere to their scheduled doses. Should patients experience unresolved symptoms, the calendar serves as a diagnostic tool to present to doctors.